Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects

Inclusion Criteria:

- Between 18 and 55 years of age inclusive, at the time of signing the informed
consent.

- Japanese subjects who were born in Japan with 4 ethnic Japanese grand parents and
must not have lived outside Japan for more than 10 years with being a Japanese
passport holder (current or expired).

- Healthy as determined by the investigator or medically qualified designee based on a
medical evaluation including medical history, physical examination, and laboratory
tests.

- Subject values for haematology and chemistry within the normal range. A subject with
a clinical abnormality or laboratory parameter(s) which is/are not specifically
listed in the inclusion or exclusion criteria, outside the reference range for the
population being studied may be included only if the investigator documents that the
finding is unlikely to introduce additional risk factors and will not interfere with
the study procedures.

- Body weight >=50 kilograms (kg) (110 pounds [lbs]) for men and >=45 kg (99 lbs) for
women and body mass index (BMI) within the range 18.5-31.0 kilogram per meter square
(kg/m^2) (inclusive).

- Male or female

Females- A female subject is eligible to participate if she is not pregnant (as confirmed
by a negative serum or urine [according to the sites standard of practice] human chorionic
gonadotrophin [hCG] test), not lactating, and at least one of the following conditions
applies:

1. Non-reproductive potential defined as: pre-menopausal females with one of the
following: Documented tubal ligation Documented hysteroscopic tubal occlusion
procedure with follow-up confirmation of bilateral tubal occlusion Hysterectomy
Documented bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous
amenorrhea (in questionable cases a blood sample with simultaneous follicle
stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on
hormone replacement therapy (HRT) and whose menopausal status is in doubt will be
required to use one of the highly effective contraception methods if they wish to
continue their HRT during the study. Otherwise, they must discontinue HRT to allow
confirmation of post-menopausal status prior to study enrolment.

2. Reproductive potential and agrees to follow one of the options listed below in the
modified list of highly effective methods for avoiding pregnancy in females of
reproductive potential (FRP) from 30 days prior to the first dose of study medication
and until 2 weeks after dosing with study medication and completion of the follow-up
visit.

The investigator is responsible for ensuring that subjects understand how to properly use
these methods of contraception.

- Capable of giving signed informed consent as described in the protocol which includes
compliance with the requirements and restrictions listed in the consent form and in
the protocol.

- Documentation that the subject is negative for the human leukocyte antigen (HLA)
B*5701 allele.

Exclusion Criteria:

- Alanine aminotransferase (ALT) >1.5x upper limit of normal (ULN) (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

- Current or chronic history of liver disease, or known hepatic or biliary
abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

- QTcF >450 millisecond (msec)

NOTES:

The QT duration corrected for heart rate (QTc) is the QTcF machine-read or manually
over-read.

The specific formula that will be used to determine eligibility and discontinuation for an
individual subject should be determined prior to initiation of the study. In other words,
several different formulae cannot be used to calculate the QTc for an individual subject
and then the lowest QTc value used to include or discontinue the subject from the trial.

For purposes of data analysis, QT interval corrected for heart rate using Bazett's formula
(QTcB), QTcF, another QT correction formula, or a composite of available values of QTc
will be used as specified in the reporting and analysis plan (RAP).

- Unable to refrain from the use of prescription or non-prescription drugs, including
vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or
14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is
longer) prior to the first dose of study medication, unless in the opinion of the
investigator and GlaxoSmithKline (GSK) medical monitor the medication will not
interfere with the study procedures or compromise subject safety.

- History of regular alcohol consumption within 6 months of the study defined as: an
average weekly intake of >14 drinks for males or >7 drinks for females. One unit is
equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5
ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

- Urinary cotinine levels indicative of smoking or history or regular use of tobacco-
or nicotine-containing products within 6 months prior to screening.

- History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy that, in the opinion of the investigator or medical
monitor, contraindicates their participation.

- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test
result at screening or within 3 months prior to first dose of study treatment.

- A positive pre-study drug/alcohol screen.

- A positive test for human immunodeficiency virus (HIV) antibody.

- Where participation in the study would result in donation of blood or blood product
in excess of 500 mL within 56 days

- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).

- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.